Cardica Adding U.S. to E.U. & Japan Sales (CRDC)

A usually quiet Cardica, Inc. (NASDAQ: CRDC) is seeing a huge move in its stock today on strong upside volume.  The company has won FDA marketing approval to sell its PAS-Port Proximal Anastomosis System for use in cardiac bypass surgery. Normally stocks do not run up this much on the actual FDA approvals, but this one had been sold off and was already well off of recent highs.

The PAS-Port system creates a secure connection between a vein graftand the main artery in the human body during coronary artery bypassgrafting procedures.  This system has been available in Japan and Europe.  The company has noted thatit has been used more than 8,800 times.  With the U.S. market now onboard, Cardica is probably going to see a surge in business.  The system is used in about 20% of the applicable cases in Japan.  The National Center for Health Statistics estimated that approximately 260,000 patients had CABG surgeriesin the United States in 2005.   Cardica also noted that each CABGprocedure requires approximately five anastomoses, often considered themost critical step of the surgery.

The PAS-Port system allows surgeons to complete an automated procedureswithout the need to clamp and manipulate the aorta, which currentlycreates clotting or scarring.

The company conducted a 220-patient, prospective, pivotal,randomized trial of PAS-Port at 12 sites in the United States andEurope. The trial met all primary and secondary endpoints.  Cardicasaid it plans on launching PAS-Port in the U.S. over the next severalweeks to surgeons and said it plans to train 50 to 60 surgeons perquarter.

This is one of the exponential winners today. Shares are up 33% at$10.70 and have already traded more than 950,000 shares so far in thefirst hour of the day.  Its normal volume for an entire day is about137,000 shares and its 52-week trading range is $5.60 to $15.15.  Evenafter today’s move, the company’s market cap is under $170 million.

Jon C. Ogg
September 9, 2008